Effect of Administration of Berberine Versus Metformin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Patients With Prediabetes
Overview
- Phase
- Phase 4
- Intervention
- Berberine
- Conditions
- Prediabetes
- Sponsor
- University of Guadalajara
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Glycosylated hemoglobin
- Last Updated
- 2 years ago
Overview
Brief Summary
Pre diabetes (PD) is a term that refers to alterations in glucose homeostasis, including impaired fasting glucose (IFG), Imparied glucose tolerance (IGT) or both, involving a higher risk to develop type 2 diabetes mellitus (T2DM) in 10 years.
The efficacy of pharmacotherapy in the prevention of diabetes in adults with prediabetes has been demonstrated, the first line of pharmacology treatment is metformin, on the other hand, the traditional Chinese and Ayurverica medicine offer potential active substances for the treatment of hyperglucemia like berberine.
Berberine is an extract with hypoglycemic effects in animal models as well as in clinical trials in type 2 diabetes mellitus even compared to metformin, for this reason comparing it's activity against metformin in prediabetes would provide impact information on a new alternative treatment and compare with the standard pharmacological treatment.
The aim of the study evaluate the effect of administration of berberine versus metaformine on glycemic control, insulin secretion and insulin sensitivity in patients with pre diabetes.
The investigators hypothesis is that the administration of berberine versus metformin modifies glycemic control, insulin sensitivity and insulin secretion in patients with prediabetes.
Detailed Description
A randomized, double-blind, placebo-controlled clinical trial in 28 patients with a diagnosis of prediabetes (IFG and IGT) in accordance with the American Diabetes Association with out treatment. They will be assigned randomly two groups of 14 patients, one of the groups will receive 850 mg of metformin twice at day (before breakfast and before dinner) and one pill of placebo (before lunch) for 14 weeks. There will be a running period, starting with a dose of 500 mg the first week, the second week increasing to 1000 mg and from the third to the fourteenth week will be a dose of 1500 mg. The other group will receive 500 mg of berberine three times at day (each one before the mealtime) for14 weeks. There will be a running period, starting with a dose of 850 mg the first week, the second week dose of 850 mg of metformin plus one placebo pill and from the third week to the fourteenth week will be a dose of 1700 mg ( two 850 mg metformin pills) plus one placebo pill. They will be measured fasting blood glucose, postprandial glucose levels and glycosylated hemoglobin, and will be calculated Area Under Curve of glucose and insulin, total insulin secretion (Insolinogenic index), first-phase of insulin secretion (Strumvoll index) and insulin sensitivity (Matsuda index). This protocol it's already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers. Statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentage for qualitative variable. Qualitative variables will be analyzed by X2, will be used for differences inter-group Mann-Whitney U Test and Wilcoxon Test for the within-groups differences. It will be considered statistical significance p≤0.05.
Investigators
Karina Griselda Pérez Rubio
PhD
University of Guadalajara
Eligibility Criteria
Inclusion Criteria
- •Patients both sexes
- •Age between 31 and 60 years
- •Diagnosis of prediabetes according 2 ADA criteria (fasting blood glucose levels between 100-125 mg/dl and postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose between 140-199 mg/dl)
- •Body Mass Index from 25 to 34.9kg/m2
- •Informed consent signed
Exclusion Criteria
- •Women with confirmed or suspected pregnancy
- •Women under lactation and/or puerperium
- •Hypersensibility to ingredients of intervention
- •Physical impossibility for taking pills
- •Known uncontrolled renal, hepatic, heart or thyroid diseased
- •Diabetes diagnosis
- •Previous treatment for glucose
- •Body Mass Index ≥35 kg/m2
- •Glycosylated hemoglobin \> 6.5%
- •Triglycerides ≥500 mg/dL
Arms & Interventions
Berberine hydrochloride
Berberine capsules, 500 mg, three per day before each meal during 12 weeks. The patients will have a forced titration period: First week they will receive one 500 mg capsule before breakfast Second week they will receive two 500 mg capsules (before breakfast and meal) From the third week until the end of the study, they will be receive three 500 mg capsules (before each meal)
Intervention: Berberine
Metformin
Metformin capsules, 850 mg, two per day before breakfast and dinner and one placebo capsule before lunch during 12 weeks. The patients will have a forced titration period: First week they will receive one 850 mg capsule before breakfast Second week they will receive one 500 mg capsules (before breakfast) and one placebo capsule (before meal). From the third week until the end of the study, they will be receive two 850 mg capsules (before breakfast and dinner) and one placebo capsule (before meal).
Intervention: Metformin
Outcomes
Primary Outcomes
Glycosylated hemoglobin
Time Frame: baseline to week 14
Glycosylated hemoglobin will be evaluated at baseline and week 14 by Elisa and the entered values reflect the glycosylated hemoglobin at week 14
Total insulin secretion
Time Frame: baseline to week 14
Total insulin secretion will be calculated at baseline and week 14 with insulinogenic index and the entered values reflect the total insulin secretion at week 14
First phase of insulin secretion
Time Frame: baseline to week 14
The first phase of insulin secretion will be calculated at baseline and week 14 with Strumvoll index and the entered values reflect the first phase of insulin secretion at week 14
Insulin sensitivity
Time Frame: baseline to week 14
Insulin sensitivity will be calculated at baseline and week 14 with Matsuda index and the entered values reflect the insulin sensitivity at week 14
Fasting glucose levels
Time Frame: Baseline to week 14
The fasting glucose levels will be evaluated at baseline and week 14 with enzymatic/ colorimetric techniques and the entered values reflect the fasting glucose level at week 14
postprandial glucose levels
Time Frame: baseline to week 14
Postprandial glucose will be evaluated at baseline week 14 after a oral glucose tolerance test with enzymatic/ colorimetric techniques and the entered values reflect the insulin sensitivity at week 14
Secondary Outcomes
- Total cholesterol(Baseline to week 14)
- Low density lipoprotein (c-LDL) levels(Baseline to week 14)
- Alanine aminotransferase (ALT) levels(Baseline to week 14)
- Creatinine levels(Baseline to week 14)
- Body fat percentage(Baseline to week 14)
- Blood pressure(Baseline to week 14)
- Body Weight(Baseline to week 14)
- Waist circumference(Baseline to week 14)
- High density lipoprotein (c-HDL) levels(Baseline to week 14)
- Aspartate aminotransferase (AST) levels(Baseline to week 14)
- Body Mass Index(Baseline to week 14)
- Triglycerides levels(Baseline to week 14)